Tools for working with CDISC ODM, CDISC Lab

and define.xml Standards

What is available ?Jozef AertsXML4Pharma

An overview of tools that ...

• Are publicly available

• Directly act on / work with ODM, Lab or CRT-DDS files

• Have been designed starting from the standard

• Concentrating on Europe

CDM Systems

• Many CDMS systems can now export in ODM format

• Some can import ODM format ...• Some have been designed with the ODM

in mind

–Easier handling of data

–ODM Conformity guaranteed

–Faster (?)

CDM Systems build on basis of the ODM

• XTrial (CRO24)

• Express (Formedix)

• Open Source: Visitrial

Study Design Tools

• Origin (Formedix)

• XC Designer (DataLabs)

• Others from Pharma companies ?

Conformity and Validation Tools

• ODMChecker (XML4Pharma)– Java based– Free for CDISC members– Small fee for non-members– Extensible (e.g. as server application)

• ODMConform (Assero)– MS based– Small fee

Viewers

• PHT CDISC Viewer – Nice ODM Viewer– Supports ODM 1.1 only– obsolete

• ODMViewer (XML4Pharma)– Similar functionality– Allows visualization of subsets– Easily extensible– Small fee

Demo at end of presentation

Test Suites

• ODMTest (Assero)– Large set of ODM files– With documentation:

• What is there• Expected results

– Currently undergoing final development

ODM – SAS Interface

• SAS Proc CDISC– Included from SAS v.9– Add-on for SAS 8.2– Downloadable from SAS website

• Tekoa Technology Toolkit (Zurich BioStatistics)

– Import / export– Free for CDISC members

Other tools for ODM(from XML4Pharma)

• Automatic transformation to e-CRFs– In XForms format, so:

•Using W3C standard

•Usable in browser, PDA, cell phone ...

• Web Services: automatic exchange between sponsor and CRO

• Reporting tool: transformation to PDF reports

Other tools for ODM(from XML4Pharma)

• Electronic Signatures in ODM: Signing and Validation tool

• Native XML database with > 3000 e-CRFs in ODM format

• Try it out yourself atwww.XML4PharmaServer.com

Tools for working with the CDISC Lab Standard

The CDISC LabChecker(XML4Pharma)

• Server application developed for Gereq• Allows conformity check of all incoming CDISC

Lab files in XML format• Web based • 21 CFR Part 11 compliant• Simplified versions available online at

www.XML4PharmaServer.com – For Lab files (base) in ASCII format (bar-

delimited)– For Lab files (base) in XML format

Demo at end of presentation

The Lab ASCII to Lab XML Converter

(XML4Pharma)

• XML implementation of Lab standard becomes important

• Tool to convert between ASCII and XML became necessary

• Online available at www.XML4PharmaServer.com

Tools for working with the define.xml Standard

Considerations

Tools for working with define.xml standard

Considerations

• The standard is very young ... but important

• Comes already with a stylesheet for HTML presentation and inspection

• Inventarization of needs and requirements

• Plans:– Extend ODMChecker for use with define.xml– ? ? ?

Demos

• ODMViewer

• CDISCLabChecker